StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems
Summary
The FDA issued a Class I for StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 by Medtronic Navigation, Inc.. Reason: In nonaxial/some axial exams if surgical plan utilized, Target Guidance selected, tip projection utilized, Navigate Projection enabled, software anoma.
Details
Source
Device Recall
External ID
Z-1666-2023
Action Date
2023-06-14
Status
Ongoing
Category
device
Product Description
StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems
Lot/Code Info: Model/UDI-DI/Software Versions: 9735585/00763000253165, 00763000306762 (inside Kits: 00763000299927, 00763000299972), 00763000517267(inside Kits: 00763000517274, 00763000517335)/v3.1.1, 3.1.2, and 3.1.3
Quantity Affected: 556
Reason for Recall
In nonaxial/some axial exams if surgical plan utilized, Target Guidance selected, tip projection utilized, Navigate Projection enabled, software anomaly may occur during tumor resection/shunt placement/deep brain stimulation, where distance to/past target text no longer synchronized with navigation information, inaccurate value displayed; may result in prolonged/additional procedure, tissue injury
Distribution
US Distribution: PR. OUS (foreign) distribution: ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BOSNIA and HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CANARY ISLANDS, CHILE, Colombia COLOMBIA, C¿TE D'IVOIRE, CROATIA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KENYA, LATVIA, MEXICO, MOLDAVIA, NETHERLANDS, PAKISTAN, POLAND, PORTUGAL, REPUBLIC of KOREA, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, THAILAND, TURKEY, UNITED ARAB EMIRATES
Type: Voluntary: Firm initiated
Recall Initiated: 2023-04-11
Company
Lafayette, CO
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 139 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Medtronic Navigation, Inc. has 23 FDA actions in our database, including 13 recalls and 10 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medtronic Navigation, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medtronic Navigation, Inc. have FDA actions?
Medtronic Navigation, Inc. has 23 FDA actions in our database, including 13 recalls and 10 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1666-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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